FDA: Vision Impairment, Other Serious Side Effects Tied to Compounded Injectable
At least 43 patients suffered serious adverse events following intravitreal injections of compounded triamcinolone and moxifloxacin, according to a new Food and Drug Administration (FDA) report.
The injection, compounded by Guardian Pharmacy Services in Dallas, TX, was administered at the end of cataract surgery at the PRG Dallas Ambulatory Surgery Center by physicians belonging to the Key Whitman Eye Center and the Park Central Surgical Center. This is not affiliated with the national long-term care Guardian Pharmacy Services, LLC, in Atlanta, GA.
The triamcinolone and moxifloxacin injection was intended for use as post-op prophylaxis for ocular inflammation and endophthalmitis to eliminate the use of post-op eye drops. In the months following the intravitreal injection, patients developed symptoms such as vision impairment, poor night vision, loss of color perception, photophobia, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and nausea. Some of these symptoms were not seen until at least one month after the surgery.
At the follow-up visits, the physicians noticed that the patients had diminished visual function affecting both visual acuity and visual fields. Macular edema was observed via optical coherence tomography testing, with some cases of retinal degeneration. Some patients experienced symptomatic improvements over the 5-month post-op period but many had a significant reduction in best-corrected visual acuity and visual fields.
The FDA does not review compounded drugs for safety, efficacy, and quality. The Agency encourages healthcare professionals and patients to report any adverse effects associated with the use of these products.
For more information visit FDA.gov.